Date:
October 18, 2021
Issue #:
1635
Summary:
On September 22, on the advice of its Vaccines and
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine (Comirnaty) to include administration of a
booster dose ≥6 months after a 2-dose primary series
in adults who are ≥65 years old or at high risk for severe
COVID-19 because of an underlying medical condition
or frequent institutional or occupational exposure
to SARS-CoV-2 (see Table 1). The FDA Advisory
Committee recommended against authorization of a
booster dose of Comirnaty for all persons ≥16 years
old, citing a lack of adequate data.
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine (Comirnaty) to include administration of a
booster dose ≥6 months after a 2-dose primary series
in adults who are ≥65 years old or at high risk for severe
COVID-19 because of an underlying medical condition
or frequent institutional or occupational exposure
to SARS-CoV-2 (see Table 1). The FDA Advisory
Committee recommended against authorization of a
booster dose of Comirnaty for all persons ≥16 years
old, citing a lack of adequate data.
